Preventive Therapy for Tuberculosis in HIV Infected Persons

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Tuberculosis Research Centre, India.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
Tuberculosis Research Centre, India
ClinicalTrials.gov Identifier:
NCT00351702
First received: July 12, 2006
Last updated: June 19, 2011
Last verified: June 2011
  Purpose

Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis in HIV infected persons

Phase: Phase III trial

Population: 650 HIV positive patients without tuberculosis

Number of sites: Three

  1. Tuberculosis Research centre, Chennai
  2. Government General Hospital, Chennai
  3. Government Rajaji Hospital, Madurai

Study Duration: 36 months

Study Objectives: To compare the efficacy of two TB preventive therapy regimens in reducing the incidence of tuberculosis and mortality among HIV-infected persons

Study Design:

The study will be a two-armed prospective randomized clinical trial among HIV- positive patients without active tuberculosis. Enrolled patients will be assigned to one of the two unsupervised self-administered treatment regimens i.e. EH for 6 months or INH alone for 3 years. At the end of a 3-year follow-up, incidence of TB and overall mortality will be compared in each group.

Study Endpoints:The primary end point of the study will be development of tuberculosis and the secondary endpoints will include adverse drug reactions and mortality rate.


Condition Intervention Phase
Human Immunodeficiency Virus
Tuberculosis
Drug: Isoniazid with Ethambutol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Two Different Preventive Therapy Regimens for Tuberculosis in HIV Infected Persons

Resource links provided by NLM:


Further study details as provided by Tuberculosis Research Centre, India:

Primary Outcome Measures:
  • Primary outcome measure is the development of tuberculosis. [ Time Frame: September 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures include adverse drug reactions and mortality rate. [ Time Frame: September 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 650
Study Start Date: February 2001
Estimated Study Completion Date: June 2011
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Isoniazid
Isoniazid (300mg) daily for 36 months
Drug: Isoniazid with Ethambutol
Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months

Detailed Description:

Study population and enrollment:

All HIV positive patients seeking care at one of the study centers, above the age of 15 years, not suffering from a serious illness, non-pregnant, and in whom TB was ruled out using the enhanced screening process, will be enrolled in the study. The consent form for prophylaxis trial will be read to the patients in the local language and written consent will be obtained from willing patients

Randomization and Dosing:

All patients enrolled in the prevention trial will be randomized to one of the study groups using a permuted block randomization scheme of four. Stratification will be done by Mantoux reading (>5mm and ≤5mm). The group assignment list will be generated centrally before the start of trial and sequentially numbered sealed envelopes containing the study group assigned will be prepared independently. At the initiation of prophylaxis, each patient will be counseled about the importance of taking drugs regularly. Patients will be asked to return the empty packets as well as unused tablets at each monthly visit.

The treatment regimens in each study group will be as follows:

  1. Ethambutol (800 mg) and Isoniazid (300 mg) daily for six months, self-administered, collected once in fifteen days.
  2. Isoniazid (300 mg) daily for 3 years with fortnightly collection of drugs Subjects in both study groups will receive 10 mg of Pyridoxine daily during treatment.
  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 15 years
  2. HIV positivity (on 2 different ELISA tests on the same blood sample)
  3. Living in Chennai or Madurai within a defined area of intake - 25 km radius.
  4. Likely to remain in the same area for at least three years after start of treatment
  5. The patient is judged to be cooperative and willing for fortnightly attendance for the next 3 years
  6. Is agreeable for home visits
  7. No major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease.
  8. No other medical condition that might interfere with management like diabetes, convulsions, serious cardiac disease.
  9. Patients who fulfill laboratory criteria (hemoglobin > 7.0g/l,granulocyte count>11,000/l, platelet count > 1 lakh/l. serum alanine amino transferase concentration < 2.5 times the upper limit of normal and serum creatinine concentration < 1.1 mgs%, random blood sugar < 140 mgs%) will be enrolled into the study.

Exclusion Criteria:

  1. Resides outside area of intake.
  2. Pregnancy and lactation.
  3. Patients with major psychiatric illnesses and severe depression
  4. Major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease
  5. Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, convulsions, cancer, moribund state
  6. Previous antituberculosis treatment for more than 1 month
  7. Patients on ART -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351702

Locations
India
Tuberculosis Research Centre
Chennai, Tamilnadu, India, 600 031
Sponsors and Collaborators
Tuberculosis Research Centre, India
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Soumya Swaminathan, MD MNAMS Tuberculosis Research Centre, India
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Soumya Swaminathan, Tuberculosis Research Centre, Indian Council of Medical Research
ClinicalTrials.gov Identifier: NCT00351702     History of Changes
Other Study ID Numbers: trc20B
Study First Received: July 12, 2006
Last Updated: June 19, 2011
Health Authority: India: Indian Council of Medical Research

Keywords provided by Tuberculosis Research Centre, India:
Preventive therapy

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Ethambutol
Isoniazid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on August 26, 2014